Senior Director, Neurosciences, Global Regulatory Affairs @ (September 2018 - March 2021)
Global Regulatory Lead @ (November 2017 - August 2018)
Head of Regulatory Affairs US and Canada (interim) @ (June 2017 - December 2017)
Lead, Regulatory Affairs - New Product Development, GE Healthcare Life Sciences @ (January 2016 - November 2017)
Boston Site Lead for the Emerging Markets Regulatory Group @ (December 2014 - August 2015)
Director, International Regulatory Affairs, Oncology Therapeutic Area @ (December 2012 - December 2014)
Director, Global Regulatory Sciences, International @ (August 2005 - November 2012)
Associate Director, Regulatory Affairs @
James Sullivan Education
Temple University
Master Of Science (Pharmacy)
2000-2004
University Of Massachusetts - Dartmouth
Bachelor Of Science
1993-1997
James Sullivan Skills
Regulations
Cross Cultural Communication Skills
Clinical Trials
eCTD
Biotechnology
Regulatory Affairs
Life Sciences
Regulatory Requirements
Pharmacovigilance
Emerging Markets
Oncology
Drug Development
GCP
Cross Functional Team Leadership
Clinical Development
u.s. Food and Drug Administration Fda
Regulatory Submissions
Pharmaceutical Industry
Therapeutic Areas
Cross Cultural Teams
FDA
IND
Medical Affairs
u.s. Food and Drug Administration
James Sullivan Summary
James Sullivan, based in Boston, MA, US, is currently a Vice President Regulatory Affairs at Ardelyx, Inc.. James Sullivan brings experience from previous roles at Ultragenyx Pharmaceutical Inc., Ipsen, GE Healthcare and Takeda Pharmaceuticals. James Sullivan holds a 2000 - 2004 Master Of Science in Pharmacy @ Temple University. With a robust skill set that includes Regulations, Cross Cultural Communication Skills, Clinical Trials, eCTD, Biotechnology and more. James Sullivan has 5 emails and 1 mobile phone numbers on RocketReach.
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